FDA 510(k) Application Details - K083702

Device Classification Name Connector, Airway (Extension)

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510(K) Number K083702
Device Name Connector, Airway (Extension)
Applicant MERGENET MEDICAL
24301 WOODSAGE DRIVE
BONITA SPRINGS, FL 34134-2958 US
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Contact PAUL DRYDEN
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Regulation Number 868.5810

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Classification Product Code BZA
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Date Received 12/15/2008
Decision Date 03/05/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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